How Prefabricated Plantar Insoles Can Reduce the Pronation

May 17, 2019 updated by: María Victoria Cáceres, University of Extremadura

Effect of the Prefabricated Plantar Insoles to Control Pronation Measured With Foot Posture Index

Pronation is a very common foot deformity in population. Plantar insoles are one way to treat it, and even correct it, but there are several kind of treatments. In this study we try to prove if prefabricated foot insoles are a solution to correct pronation in adults. It has been tested by Foot Posture Index, that it is an objetive clinical test to measure the posture of feet. Foot is clasified in supinated , pronated and neutral.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nowadays several treatments have been described to treat pronation foot posture, althought these ones heven´t proved objetively the improvement and progression of foot deformity like "Foot Posture Index" does,. Foot pronation during walking is a physiological movement at the beginning of stance phase. It is a needed mechanism which allows the lower limb muscles to support the reaction forces from the ground and to give the forefoot wider range of movement . When there is pronation movement in weight bearing of subtalar joint, the calcaneus does a movement of eversión while talus does a plantarflexion and movement of aduction .The movement is raised due to the paralelism of midfoot joints and the forefoot is forced to compensate the rearfoot position, gettting into dorsiflexion and abduction which leads to a flattening of the medial arch. it is known pronation or flatfoot. Pronation movement is a pathology when it happens during the second part of the stance phase, the 25% at the beginning or when deformity is abnormal provoking an excessive rearfoot eversion with flattenig of the medial arch which will lead to a lower limb misalignment . This doesn´t allow the foot to be a rigid part needed to propulsion phase, so muscles must work excessively to give balance. The pronated foot etiology can be congenital or laxity or due to triceps sural shortening, or functional etiology like varus forefoot, metatarsus aductus or tibial posterior insufficiency. There are some secundary painful pathologies which are the most frequent reason of podiatric appointment.. Plantar fascitis is one of the pathologies, and adquired deformities like Hallux Abductus Valgus, Hallux Límitus/Rigidus and other lower limb deformities like medial compatiment ostheoartritis of knee or patellofemoral syndrome.

Pronated foot can be defined like a foot that has rearfoot eversion and medial protusion of the head of talus, forefoot abduction, flatted medial arch and joint movement greater. This shows a flat foot aspect, depending on the grades of pronation deformity that pacient presents. Both situations are linked and their behaviour are functionally similar.

Attending on consequences and the pathologies derivated of this deformity there are some treatments to stop it and avoid structural alterations of leg and foot. For instance, hallux abductus Valgus, the pathological pronation is the first ray´s extrinsic ethilogic factor, both frequency and capacity to produce pathology.

The compensation of pathological pronation of rearfoot is important to control the deformity evolution. Is commonly accepted by podiatric scientific community that control of pronation can avoid the deformity progression when it is presented (or this progression was slower) and avoid when it wasn´t present yet. Foot Posture Index is a clinical diagnostics tool compounds by 6 criteria that allow to asses reliability the weightbearing foot posture. It is a inexpensive and simple method that doesn´t imply risks to people.

Study Type

Observational

Enrollment (Actual)

153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

'Participant were pupils of Podiatric, Nursing, Forestry and Economic grades of University of Extremadura in Plasencia Campus, Spain. All of the came to Podiatric University Clinic Of University of Extremadura, Spain to be recruided in the present study. After to be informed of the features and targets of this study, they were be given an informed consent, answering the doubts. All of them signed the informed consent and they were asked to be engaged to use the right shoes with plantar insoles all the week , 8 hours at least for 6 months.

Description

Inclusion Criteria:

  • feet without symptom
  • not present joint deformities to difficult the right measure of them
  • aged between 18 to 50 years

Exclusion Criteria:

  • don´t have degenerative ostheoarticular deformities
  • don´t have surgery iinterventions of lower limbs
  • balance problems
  • painful keratopaties or plantar warts that difficults stance phase
  • use of others orthopaedics treatements (plantar insoles)
  • don´t be able to step correctly and coordinated on platform to inspect the foot posture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
control group in which all of them present pronated foot without tratment
experimental group
Group in which they have been treated with prefabricated plantar insoles to stop pronation
Device: prefabricated insoles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Posture Index
Time Frame: 5 minutes total assessment
Foot Posture Index is a diagnostic tool to measure the foot posture while it is weightbearing. The Foot Posture Index is a 6-item foot posture assessment with the subject standing relaxed in a bipedal position, The 6 items of FPI include talar head palpation, curves above and below the lateral melleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch and forefoot to rearfoot alignment. Each item was scored on a 5-point scale between -2 and +2 and provides a total sum of all items between -12 (highly supinated) and +12(highly pronated).
5 minutes total assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Extremadura

Investigators

  • Study Director: Julian F Garcia, Nursing, University of Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2013

Primary Completion (ACTUAL)

November 20, 2014

Study Completion (ACTUAL)

January 30, 2017

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (ACTUAL)

May 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UExtremadura

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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